Kanjinti Clinical Development Timeline
Executive Summary
Chronicle of the development and review of Amgen’s biosimilar to Genentech’s Herceptin.
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Kanjinti’s Path To Market Complicated By GMP Issues, Reference Product Drift
US FDA licensure of Amgen’s biosimilar to Herceptin was delayed by a complete response letter citing product manufacturing facility deficiencies; review documents discuss how drift in Genentech's reference product impacted the biosimilar program's analytical and clinical data.
Kanjinti Reviewers
US FDA staff who participated in the review and approval of trastuzumab-anns, Amgen’s biosimilar to Herceptin.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.